Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: A North Central Cancer Treatment Group Study
Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: A North Central Cancer Treatment Group Study
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DOI：
10.1200/jco.20.2.567
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发表时间：
2002-01-15
影响因子：
45.3
通讯作者：
Christensen, B
中科院分区：
文献类型：
--
作者：
Jatoi, A;Windschitl, HE;Christensen, B
目的：确定单用或合用甲地孕酮治疗癌症相关性厌食的疗效是否优于单药甲地孕酮。患者和方法：469例可评估的晚期癌症患者随机分为(1)口服甲地孕酮800 mg/d混悬液加安慰剂，(2)口服屈诺松醇2.5 mg/d加安慰剂，或(3)两种药物同时服用。符合条件的患者承认食欲减退或体重下降是一个问题，并报告在2个月内体重减轻5磅或更多，和/或每天摄入的热量低于20卡路里/公斤体重。结果：在年龄、性别、肿瘤类型、体重减轻和表现状态方面，各组在基线方面具有可比性。接受甲地孕酮治疗的患者报告的食欲改善和体重增加的比例高于接受屈诺比诺治疗的患者：食欲改善的比例为75%，基线体重增加超过或等于10%的患者，食欲改善的比例为11%，体重增加的比例为49%(P=0.0001)，体重增加的比例为3%(P=0.02)。联合治疗与单独使用甲地孕酮相比，在食欲或体重方面没有显著差异。强调厌食相关问题的厌食/恶病质治疗功能评估问卷显示，接受甲地孕酮治疗和联合治疗的患者的生活质量(QOL)得到了改善。单项Uniscale，全球生活质量。乐器，找到了可比的分数。毒性也是相似的，除了服用甲地孕酮的男性阳萎发生率增加。结论：在我们研究的剂量和时间表中，甲地孕酮对晚期癌症患者的厌食缓解作用优于单用屈诺比诺。联合治疗似乎没有带来额外的好处。(C)2002年，由美国临床肿瘤学会提供。
Purpose: To determine whether dronabinol administered alone or with megestrol acetate was morel less, or equal in efficacy to single-agent megestrol acetate for palliating cancer-associated anorexia.Patients and Methods: Four hundred sixty-nine assessable advanced cancer patients were randomized to (1) oral megestrol acetate 800 mg/d liquid suspension plus placebo, (2) oral dronabinol 2.5 mg twice a day plus placebo, or (3) both agents. Eligible patients acknowledged that loss of appetite or weight was a problem and reported the loss of 5 pounds or more during 2 months and/or a daily intake of less than 20 calories/kg of body weight.Results: Groups were comparable at baseline in in age, sex, tumor type, weight loss, and performance status. A greater percentage of megestrol acetate-treated patients reported appetite improvement and weight gain compared with dronabinol-treated patients: 75% versus 49% (P = .0001) for appetite and 11% versus 3% (P = .02) for greater than or equal to 10% baseline weight gain. Combination treatment resulted in no significant differences in appetite or weight compared with megestrol acetate alone. The Functional Assessment of Anorexia/Cachexia Therapy questionnaire, which emphasizes anorexia-related questions, demonstrated an improvement in quality of life (QOL) among megestrol acetate-treated and combination-treated patients. The single-item Uniscale, a global QOL. instrument, found comparable scores. Toxicity was also comparable, with the exception of an increased incidence of impotence among men who received megestrol acetate.Conclusion: In the doses and schedules we studied, megestrol acetate provided superior anorexia palliation among advanced cancer patients compared with dronabinol alone. Combination therapy did not appear to confer additional benefit. (C) 2002 by American Society of Clinical Oncology.